BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW 7XB

    MDR report key: 1037582 · Received May 1, 2008

    Report

    Report Number
    MW5006537
    Event Type
    Injury
    Date Received
    May 1, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 1, 2008
    Manufacturer
    GUIDANT
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGEON USING VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM WHEN GUIDANT REP NOTICED AN UNUSUAL REFLECTION FROM SCOPE. FURTHER EXAMINATION REVEALED A MINUTE PARTICLE. REP FELT THAT PARTICLE WAS FROM KNIFE OF HARVESTING SYSTEM. SURGEON MADE INCISION AND SUCCESSFULLY REMOVED PARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7XB ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ GUIDANT * 8013071

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention